Author: Peter

If drugmakers foreign and domestic are counting on a return to reaping big benefits once China bounces back from its recent economic decline, they may wish to take another look. The economy may not be the problem; it is in the design of the nation's huge healthcare system…That is the conclusion of a lengthy look at the healthcare situation, including pharmaceuticals, in China by London's Financial Times…China has been engaged in a huge expansion of its healthcare system for the past several years, aimed primarily at getting care to all parts of the vast country, primarily its rural parts… while demand was increasing for pharmaceuticals, medical devices and other healthcare items, China needed to rein in the costs of the system and operate it more efficiently…China especially saw a need to get more bang from its $150 billion spent on pharmaceuticals at the same time a new government focused on ending corruption, which in healthcare centered on a hospital system that relied on drug sales for adequate income…“the whole health system is unbalanced,"…

Chronic conditions, such as arthritis, can be debilitating…One way to help patients…manage their condition is to follow their medication regimens…pharmacists are uniquely positioned to help these patients understand why taking their medications as prescribed is fundamental to their health…Poor medication adherence – not taking medications as prescribed – costs the…healthcare system $290 billion annually in emergency room visits and catastrophic care. There is a solution…Medication therapy management is a…service offered by pharmacists…that helps ensure medications are taken appropriately to help improve health, reduce the risk of adverse events, and help control healthcare costs…Pending bipartisan legislation in the U.S. Senate – S. 776, the Medication Therapy Management Empowerment Act of 2015 – would improve access to MTM services for senior citizens enrolled in the Medicare program. Medicare Part D patients with specific chronic conditions would benefit from the education and training of pharmacists… to help ensure that medications are taken appropriately…CMS has also recently announced a pilot initiative to enable Medicare Part D plans the opportunity to utilize new and innovative approaches to MTM, which can lead to improved patient access to MTM services and greater medication adherence.

Never mind that report in a scientific journal last month that a new superbug resistant to all antibiotics might go global. It already has, according to a scientific magazine…Danish researcher Frank Aarestrup said he has found the mcr-1 gene in one person in Denmark and in 5 samples from poultry meat imported from Germany more than two years ago. He said the gene is the same as the one found in China…The finding that bacteria with that gene were resistant to the last-standing effective antibiotic, colistin, prompted fears of apocalyptic germs spreading around the world. The discovery at Southern Agricultural University in China was believed to be the first case of mrc-1 (mcr-1) found in humans…If the gene's presence leads to a global pandemic, infections that normally would be treated with antibiotics would become incurable unless new types of antibiotics make their way onto the market in time.

The American College of Cardiology has recognized pharmacists as advanced practice providers, valuable to car­diovascular team-based care…sees this as an inspiring time, encour­aging other historically physician-driven, non-pharmacist organizations to support pharmacists, as they push for healthcare provider status…“ACC recognizes that there’s a shortage of cardiologists,”…The ACC recognizes that there’s a lot of work to go around but not enough cardiologists to do it. They see the benefit of advanced practice providers, which includes pharma­cists, nurse practitioners and physician assistants, and they believe that’s the way to make it happen…to offer care where care isn’t being given.”… With the ACC’s backing, there’s hope that other non-phar­macist organizations will support pharmacists...

India will join more than 110 countries that have introduced the injectable inactivated polio vaccine to their calendars. Sanofi and its Indian affiliate, Shantha Biotechnics, will supply polio vaccines to the Indian government via UNICEF. The vaccines will be used in India's universal immunization program…Sanofi Pasteur has already supplied the government with its Imovax Polio vaccine, and Shantha will soon follow suit with its ShanIPV. While oral polio vaccines have previously been included in the nation's universal immunization program, the WHO recommends replacing it with the injected inactivated vaccine…While India is officially polio-free, it borders Pakistan and Afghanistan, which still report polio cases…With the introduction of IPV in their immunization schedule, India moves the world much closer to being polio-free…

The U.S. Treasury's latest stab at deflecting tax inversions deals has persuaded at least one player to give up plans for a move to Ireland, but not from looking outside the U.S. for some tax relief. Pozen, which was headed to Ireland as part of its merger plans with Tribute Pharmaceuticals, will set up shop instead in Tribute's home turf of Canada…The two drugmakers said recently they charted the change of course "after reviewing the recent guidance from the Treasury's Notice 2015-79 issued on November 19, 2015 and its potential impact on the proposed transaction."…Pozen and Tribute recommitted to their merger but said that they will go to Canada instead…The new company, which will be renamed Aralez Pharmaceuticals, has a $350 million commitment from a syndicate led by private equity firm Deerfield Investments.

Four people (Dr. Michael Kelly, Priscilla Orosco, Joyce James, Tamara Mitchell) have been charged in a $17 million health insurance fraud scheme involving the sale of ketamine to patients without a valid prescription…The four-count indictment alleges Mitchell was an owner of two pharmacies, Diamond and Save Rite, that sold controlled substances as part of a marketing scheme, rather than for legitimate medical need. Diamond Pharmacy and Save Rite almost exclusively sold compounded creams containing prescription drugs and ketamine to the public by using pre-signed prescriptions to fill orders for customers, who had the “right” insurance plans, according to the charges…Mitchell allegedly hired pharmacy technician Orosco and pharmacist James to conduct the day-to-day operations of the business…Diamond Pharmacy paid (Dr.) Kelly thousands of dollars per month to provide pre-signed prescriptions without examining patients. Diamond and Save Rite (pharmacies) then allegedly billed insurance companies for compounded creams containing controlled substances…the four…face up to 20 years in federal prison and a possible $250,000 maximum fine. They also face another 10 years for both the conspiracy to distribute and for aiding the distribution of Ketamine as well as a possible $500,000 fine.

Sanofi's dengue vaccine is to make its market debut in Mexico, the French drugmaker said…adding that it expects to have filed for market approval in some 20 countries by year-end…the preventive treatment, called Dengvaxia, for all four dengue virus serotypes, but only for patients aged 9 to 45 who live in areas where the disease is endemic…This means the world's first dengue vaccine has no approval yet for use on young children, a population considered to be most at risk, or for use by tourists…Dengue fever is a mosquito-borne disease caused by four virus serotypes as categorized by the World Health Organisation...the disease is seen as a threat to about half of the world's population. Some 400 million people are believed to be infected annually...

India may be sitting on a pharmaceutical gold mine. It has more than 7 times the number of people affected by rare diseases than the United States, a less expensive workforce for making drugs and an often-criticized price-control system that, by definition, does not affect orphan drugs…One India-based company sees a profitable outcome for its orphan drug, a sign the nation could become a major source of the often-overlooked treatments as other drugmakers watch to see if the optimism is justified and lasts… India offers the advantage of cheaper drug development, orphan drugs often have already produced or at least studied relatives, and many of them…are curative, thus reducing the burden on healthcare systems. And, it has a lot more potential patients.

Health IT Now, along with eight other organizations…are calling on Congress to stay the course on Stage 3 of the Meaningful Use EHR Incentive Program…Health IT Now describes itself as a broad-based coalition of patient groups, provider organizations, employers and payers…The coalition, along with eight other organizations made their pleas in a…letter…"We write to urge you to oppose any legislative changes to the meaningful use program, including delays in the timing of Stage 3, that do not also include reforms to improve the interoperable use of health information technology,"…"Delay without reform would rob taxpayers and patients of cost savings while doing absolutely nothing to make the program work well for overburdened doctors and hospitals."…The American Medical Association and 111 other national and state medical societies called for delay of Stage 3 in an earlier letter to leadership...